FDA Approves Daratumumab and Hyaluronidase-fihj for Multiple Myeloma

On May 1, 2020, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.

Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received:

• in combination with bortezomib, melphalan and prednisone  in newly diagnosed patients who are ineligible for autologous stem cell transplant,
• in combination with lenalidomide and dexamethasone  in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy,
• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy,
• as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.